Prime Entecavir Tablet

Adult dose

This drug should be administered orally on an empty stomach (2 hours after a meal or at least 2 hours before a meal). Administer entecavir 0.5mg orally once daily. Patients 16 years of age or older who are resistant to lamivudine, i.e., who have experienced persistent replication of hepatitis B virus despite lamivudine treatment or have lamivudine-resistant mutations: Administer entecavir 1mg orally once daily on an empty stomach. Patients with renal impairment: In patients with renal impairment, the oral clearance of this drug decreases as creatinine clearance declines. Adjust the dose as follows in patients with creatinine clearance below 50mL/min, including those receiving hemodialysis or continuous ambulatory peritoneal dialysis (CAPD). Creatinine clearance (mL/min) ≥ 50: Entecavir dose 0.5 mg once daily; entecavir dose in patients resistant to lamivudine 1 mg once daily Creatinine clearance (mL/min) 30 - <50: Entecavir dose 0.25 mg a once daily or 0.5 mg every 48 hours; entecavir dose in patients resistant to lamivudine 0.5 mg once daily or 1 mg every 48 hours Creatinine clearance (mL/min) 10 - <30: Entecavir dose 0.15 mg a once daily or 0.5 mg every 72 hours; entecavir dose in patients resistant to lamivudine 0.3 mg a once daily or 1 mg every 72 hours Creatinine clearance (mL/min) <10, hemodialysis b or CAPD: Entecavir dose 0.05 mg a once daily or 0.5 mg every 7 days; entecavir dose in patients resistant to lamivudine 0.1 mg a once daily or 1 mg every 7 days a: For doses below 0.5mg, use of the oral solution is recommended. b: If administered on a hemodialysis day, administer this drug after the hemodialysis session.

Child dose

Dosage is specified only for patients over 16 years of age with lamivudine-resistant mutations, and there is no separate dosing method for children under 16 years of age.

This medicine can cause serious side effects such as lactic acidosis and hepatic steatosis in patients with severely impaired liver function; therefore, patients with a risk of liver disease should exercise particular caution. If this medicine is discontinued, hepatitis may worsen rapidly; therefore, liver function tests should be performed regularly for several months after stopping treatment. In patients co-infected with HIV and hepatitis B who are not receiving HIV treatment, the use of this medicine may lead to resistance to HIV treatment and is not recommended. Patients who are allergic to this medicine or its components, and those with certain genetic disorders such as lactose intolerance, should not take this medicine. Patients with impaired kidney function or those undergoing hemodialysis should adjust the dosage of this medicine, and patients who have had liver transplants should carefully monitor their kidney function. During treatment with this medicine, side effects such as headaches, fatigue, dizziness, and nausea may occur, and if signs of liver function abnormalities appear, immediate consultation with a healthcare provider is required. Pregnant women should use this medicine only after carefully considering the risks and benefits to the fetus, and nursing mothers should reconsider using this medicine because it may be excreted in breast milk. It is recommended to take this medicine on an empty stomach; administration with food may reduce absorption by approximately 20%. Since this medicine is primarily excreted by the kidneys, caution is needed when using it with other medications that affect kidney function or interfere with renal excretion, as the risk of side effects may increase. Elderly patients may require dose adjustments and kidney function testing because drug concentrations may increase due to impaired kidney function. No specific harm has been reported in case of overdose; however, patients should be closely monitored and appropriate treatment should be administered if necessary. This medicine should be kept out of reach of children, and tablets should be stored in a tightly sealed container at room temperature, while syrup formulations should be stored in opaque, tightly sealed containers.

• Lactic acidosis
• steatosis
• hepatomegaly
• hepatic metabolic dysfunction
• headache
• fatigue
• dizziness
• nausea
• diarrhea
• dyspepsia

This medicine should be stored in a tightly closed container to protect it from exposure to air and light. It is also recommended to store it at room temperature between 15 to 30 degrees Celsius. Storing it this way helps maintain the medicinal effects for a longer period.

Appearance

White to grayish-white triangular film-coated tablet

Package unit

30 tablets (10 tablets/PTP x 3)